FDA probe of US Abbott facility finds quality control issues
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[BENGALURU] An inspection at the Abbott Laboratories facility in Sturgis, Michigan found a harmful bacteria on surfaces in some areas of its powdered baby formula production, the US health regulator said on on Tuesday.
The bacteria, Cronobacter sakazakii, can cause severe foodborne illness in mainly infants.
Complaints that the facility's products had caused bacterial infections forced Abbott to recall certain Alimentum, Similac and EleCare baby formulas last month, prompting a probe from the US Food and Drug Administration (FDA).
The inspection from Jan 31 to March 18 showed that Abbott did not have a control system covering all stages of processing to prevent microbe contamination of infant formula.
Personnel working with infant formula also did not wear necessary protective apparel, the FDA said.
The observations raised are not final and the company can take corrective measures to address the issues raised, according to the agency. REUTERS
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